Senior Regulatory Specialist (m / f / d) - IVD

Agilent; Les Ulis; Hybride; EUR 50 000 - 80 000; Plein temps

Résumé du poste

An established industry player is seeking a highly motivated Senior Regulatory Specialist to join their Global Regulatory Affairs team. In this exciting role, you will be instrumental in supporting new product introductions and ensuring compliance with global regulatory standards. You will prepare documentation for international submissions, develop regulatory strategies, and lead projects that involve collaboration with various departments. This position offers the flexibility of remote work and the opportunity to grow within a diverse and inclusive environment. If you are passionate about regulatory affairs and want to make a difference in the life sciences field, this role is perfect for you.

Prestations

Private healthcare

Pension

Stock plans

Insurance

Work-life balance support

Growth opportunities

Diverse, inclusive work environment

Qualifications

• Experience in a regulated environment and knowledge of international registration processes.
• Strong teamwork and leadership skills across functions and geographies.

Responsabilités

• Support new product introduction projects and develop regulatory strategies.
• Prepare documentation for regulatory permits, licenses, and registrations.

Connaissances

Regulatory Affairs

Quality Assurance

Project Management

Communication Skills

Problem-Solving

Formation

Bachelor’s degree in Regulatory Affairs or related field

Outils

SAP

Description du poste

Description

Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Want more information on Agilent? Check out our website!

We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team. In this role, you will support new product introduction projects, develop regulatory strategies, coordinate and track international submissions, product change notifications, product release, licensing requirements, and registration of IVD products for Agilent.

This position ensures products are received, licensed, and delivered in accordance with global regulatory and quality standards. As a member of the Global Regulatory Team, you will support international IVD registrations, including:

1. Preparing document packages for regulatory submissions and listings to ensure compliance with local and regional requirements.
2. Compiling materials required for submissions, license renewals, and annual registrations. Maintaining export licenses within SAP for IVD licenses and addressing global trade holds.
3. Developing and implementing programs to ensure products are safe, legal, and meet customer expectations for compliance with regulations.
4. Problem-solving and raising regulatory issues to senior management as needed.
5. Monitoring regulatory changes and participating in discussions related to regulation updates, assessing impacts, and communicating risks and opportunities.
6. Leading regulatory projects involving coordination with Legal, Marketing, Project Management, and distributors.
7. Supporting regulatory impact assessments for change controls.
8. Preparing documentation for regulatory permits, licenses, and registrations.
9. Consulting with regulatory agencies for guidance.
10. Communicating with Channel Partners regarding registrations and changes.

This role is preferably based in Waldbronn, Germany (hybrid), but can be located anywhere in Europe with an Agilent entity.

Qualifications

1. Bachelor’s degree in Regulatory Affairs, Quality Assurance, engineering, or a related science field.
2. Relevant experience in a regulated environment.
3. Knowledge of international registration processes.
4. Strong teamwork and leadership skills across functions and geographies.
5. Experience with Quality Management Systems in the medical device industry.
6. Proficiency in English communication.
7. Experience working with global teams.

Preferred Qualifications

1. Excellent communication, project management, and presentation skills.
2. Knowledge of design controls and standards such as ISO 13485 and 14791.
3. Experience with regulated products and ISO Quality standards.

We offer :

1. Core global benefits, plus bonuses, private healthcare, pension, stock plans, and insurance (varies by country).
2. Growth opportunities within a global company.
3. Diverse, inclusive work environment.
4. Autonomous role in a caring, fast-paced environment based on integrity and trust.
5. Exciting projects in a collaborative, agile culture.
6. Work-life balance support.
7. Permanent contract in a growing global firm.

We look forward to your application in English. Agilent is recognized as one of the best employers worldwide: Awards | Agilent Technologies

Additional Details

This is a full-time position with options for remote work. Pay ranges are role, level, and location-dependent. During hiring, specific pay details will be provided. Agilent is an equal opportunity employer, considering all qualified applicants without discrimination.

Travel Required : 10% of the time

Shift : Duration :

No End Date

Job Function : Quality / Regulatory